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Job

VP, Global Regulatory Affairs

  • Location

    New York, NY, USA

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Salary:

    Competitive

  • Contact:

    Olivia Gonzalez

  • Contact email:

    o.gonzalez@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    23 days ago

  • Expiry date:

    2019-03-02

  • Startdate:

    ASAP

A Stealth Biotech in the Greater New York City area is currently searching for a Vice President of Global Regulatory Affairs to lead their Regulatory function. 

This role will report into the CEO and will have Quality & Compliance oversight. It is an extremely exciting time to join this company. 

The lead program will be an extremely high visibility program with a completely novel therapeutic approach and efficacy already demonstrated in the clinic. 

 

Responsibilities:

  • Provide strategic regulatory leadership and maintain global responsibility for all development projects, including regulatory strategy, regulatory requirements for global registration, and regulatory risk assessments and mitigation for all programs
  • Prepare and develop plans and registration strategies that will ensure worldwide regulatory submissions that align with key business objectives
  • Prepare briefing and regulatory documents for regulatory agencies, such as Dossiers, NDAs, INDs, and annual reports
  • Provide regulatory strategy and input to all non-clinical and clinical programs including clinical, toxicology, pharmacology and CMC
  • Ensure that all the manufacturing and quality programs relevant to CMC/Pharmaceutical development are structured appropriately for regulatory requirements
  • Anticipate the impact of the changing domestic and international regulatory environment, existing legislation and guidelines on the development of plans, registration strategies and post-marketing maintenance in order to execute program objectives in compliance with applicable regulations
  • Ensure the safe, compliant, and robust integration of documentation from new product acquisitions and due diligence activities
  • Initiate and contribute to the development of policies and procedures in compliance with GxPs etc.
  • Oversee Quality & Compliance staff
  • Collaborate with clinical, commercial, CMC, business development, and Legal in the development of strategies to strengthen the exclusivity of the company’s IP
  • Ensure that biologic programs receive regulatory approval by key regulatory bodies in the US, EU, Asia, and Latin America

 

Qualifications:

  • Advanced degree in a science-related discipline or relevant experience demonstrating scientific competence
  • 15+ years of pharmaceutical industry experience, at least 10 of which include regulatory responsibilities
  • Rare Disease experience a plus
  • Strong knowledge of current US and EU regulations, including novel regulatory pathways
  • Strong experience with CTD format and content regulatory filings
  • Thorough knowledge of the drug development process, with a focus on IND/CTA and NDA/BLA/MAA processes
  • Knowledge of and broad experience with regulatory procedures and legislation for drug development, product registration, line extension and license maintenance (preferably from at least both US and EU)
  • Knowledgeable of GxP environment cGMP, GLP, GCP environments and regulations experience required
  • Knowledgeable of US standards 21CFR210, 21CFR211, 21CFR11 and ICH Quality guidelines
 
If you are interested in this or similar roles, please contact Olivia Gonzalez at o.gonzalez@hamlynwilliams.com.